Sarcoma Oncology Research Center, LLC
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously. A total of 80 patients will receive trabectedin 0.5 mg/m2 as 24 hour continuous intravenous infusion (CIV) on D1 and D8, gemcitabine 200 mg/m2 i.v. on D1 and D8, and dacarbazine 200 mg/m2 i.v. on D1 and D8 (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not c…
Inclusion Criteria: * Male or Female ≥ 18 years of age * Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma * Previously treated patient with measurable disease by RECIST v1.1 * ECOG performance status ≤ 2 * Life expectancy of at least 3 months * Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \< 2.5 x ULN (\< 5 x ULN if liver metastases present) * Acceptable renal function: Creatinine \< 1.5 t…
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Arctuva estimate
Verify or correct the compensation shown for this listing.